Pharmaceutical Association of Malaysia

Research and Development is a cornerstone of all innovative biopharmaceutical companies, with billions of dollars spent in Clinical Research annually to bring advancements in medicine and healthcare. But if you think Clinical Research only involves lab work, you will be in for a surprise! The roles within the Clinical Research sector covers a wide scope, across different companies, depending on your job function. In short, it is an exciting career pathway for people who love science and appreciate the process of drug discovery. Join our Introductory Programme on Clinical Research on 9 Jan, which will feature speakers from Clinical Research Malaysia and top biopharmaceutical companies involved in clinical research. Places are limited. Register now to reserve a slot: http://t2u.asia/e/38512

The Japan Pharmaceutical Manufacturers Association(JPMA) paid a courtesy visit to PhAMA on 26 November for a knowledge-sharing session on common goals and enhancing organisational excellence. Among the main discussion points was the 14th Asia Partnership Conference of Pharmaceutical Associations (APAC) 2025 which will be held in April in Tokyo. The annual conference provides a platform for regulators, government representatives and R&D-based pharmaceutical associations across the region to discuss healthcare challenges in Asia and seek solutions from neighbouring nations. Themes for the upcoming year include Asian Universal Health Coverage, e-labelling, and Manufacturing, Quality Control, and Supply (MQS) and microbiome health. The visit helped to strengthen bonds and forge new partnerships which will be mutually beneficial for both JPMA and PhAMA in expanding the reach of innovative medicines for people in Asia.

As 2024 draws to a close, PhAMA held our annual Gala Dinner on 22 November at the Le Meridien Petaling Jaya to celebrate the achievements and hard work of members for the year. The event, themed glitter and sparkle, brought together all PhAMA members in their shimmery best, as they reconnected with old friends and made new connections. In her welcome speech, PhAMA President Ms. Ai Teng Kam mentioned that 2024 has been an eventful year for the industry, with internal and external pressures from many angles including domestic, regional and global offices. Throughout the year, PhAMA has been working hard to ease those pressures for all members. We thank all guests and company members for their trust and collaborative spirit in increasing access to innovative medicines in the country. For photo album: https://lnkd.in/gBiTKFwx

We are saddened to hear about the demise of Mr Yeap Boon Chye, who was among one of PhAMA's earliest leaders. The late Mr Yeap was a towering figure in the fields of Pharmacy and the pharmaceutical industry, with his name etched in the memories of many senior pharmacists. In 1973, he stepped into the shoes of his predecessor, the late Mr Lee Sze Peng, as the Chief Pharmaceutical Chemist of the Pharmacy Division. He later became the first Director of Pharmaceutical Services, serving with distinction until his retirement in 1986. An epitome of dedication, Mr Yeap was conservative, serious, and businesslike, always upholding the highest standards of governance in public service. After retirement, he embraced a new chapter as the first Executive Director of PhAMA, representing the pharmaceutical industry—a role that helped to bring the Industry closer to the MoH especially the Pharmaceutical Service Division. A well-respected man of integrity, he was engaging and warm. His demise marks the loss of yet another iconic figure who helped shape the early years of pharmacy practice in Malaysia. His legacy of service and leadership will forever inspire those who follow in his footsteps. May his soul rest in eternal peace.

The 3rd WHO meeting to support the ASEAN Joint Assessment (AJA) and Advocacy Workshop to Industry was held in Jakarta on 15 November 2024, back-to-back with the 12th Annual Meeting on “Collaborative Registration Procedure (CRP) - Reliance through Facilitated Product Introduction” which was held on 12-14 November 2024. The Workshop was attended by more than 250 participants from 9 ASEAN countries, supporting SRAs (PMDA, TGA, EMA) and industry. PhAMA had the opportunity to get updates and discuss on the ASEAN JA procedure and its implementation, as well as engagE with ASEAN regulators and other stakeholders to enhance this ASEAN facilitated registration procedure. Alice Chee, representing PhAMA as Chair of APRIA, presented on the industry’s experience with ASEAN JA procedures and proposals/recommendations for its further improvement. APRIA’s recommendations included: 1) Further improvements to the AJA timelines 2) Incorporation of Post-Approval Changes in the AJA procedure 3) Timing flexibility in the final national submission of the M1 module 4) Minimising Country-specific requirements The CRP workshop held concurrently was attended by more than 350 registered participants from many parts of the world. Knowledge was gained through experiences shared by CRP implementing NRAs, SRAs and WHO, on the benefits of applying reliance approaches using CRP, and also better understanding on the SRA and PQ activities related to assessment, inspections/audits and evaluations (IVDs) for WHO-prequalified and SRA-approved products. The annual meeting on the Collaborative Registration Procedure (CRP) was organized to support accelerated national registration of prequalified medicines, vaccines, in-vitro diagnostics (IVDs), and products approved by SRAs, where the accelerated registration for WHO-prequalified products and SRA-approved medicines in participating countries is through the reliance on shared confidential assessment or inspection reports generated by the WHO Prequalification Team or SRAs.

Health Ministry is considering integrating AI to enhance disease detection, particularly for cancer, in public hospitals, pending validation of its safety, efficacy, and cost-effectiveness. AI has shown promise in improving diagnostic accuracy and early detection, with ongoing evaluations by MaHTAS for lung, breast, and cervical cancers. Initial studies indicate AI’s effectiveness in assisting radiologists, especially in lung cancer detection, by improving sensitivity and reducing false positives. While AI shows potential in breast and cervical cancer screening, more robust evidence is needed before widespread adoption. Trials are underway at key hospitals to assess broader implementation. Read more: https://ow.ly/hvOb50Ubtrz

PhAMA's signature Career Day returns for the second year last Saturday (16 Nov 2024), bringing together over 300 students from 26 universities across the country! Kicking off the morning session was a keynote speech by Abdullahi Sheriff, followed by experience-sharing sessions by industry captains Aveenashpal Ganapathy, Mohamad Fauzi Zakaria, RPh Tse-Ming PANG and LG (Louis-Georges) LASSONNERY, moderated by Deepti Saraf. Each speaker described his/her career journey and lessons learnt throughout their different life paths, driven by the common traits of resilience, tenacity and adopting a growth mindset. The afternoon sessions featured technical talks by 19 experienced speakers holding different roles in their respective companies, from Policy and Government Affairs, Market Access & Procurement, to Clinical Research, Sales & Marketing, Ethics & Compliance, Supply Chain & Logistics, Regulatory Affairs, Medical Affairs and Enabling Functions (HR, Finance, IT, Communications, etc) . Each talk described the role covered, basic requirements, success factors and more. The speakers also shared briefly their career pathways, many of which took different twists and turns before they found their true calling. The Career Day hopes to raise awareness of the different opportunities within the pharmaceutical sector for all graduates, not confined to pharmacy or life sciences streams. A resume drop was also provided for students seeking roles in PhAMA member companies. We extend our sincere gratitude to everyone who had contributed in one way or another towards our Career Day 2024. To the students who attended our event, we wish you every success in your career path! Photo album: https://lnkd.in/gBGtUtKC Pixie Yee | Ai Teng Kam | Li Jin CHAN | Nur 'Ainatul Mardhiah | Janice Law | Dr Azhar Ahmad 🩺| Sarega Nadarajan. Ph.D | EeLaine Tan | Tia Chen | Nigel Fong | Shamie Zainal | Loong Tek Tee | E-Kon Tan | Jasmine Ng

Research & Development is an integral component of many multinational innovator pharmaceutical companies in the continuous search for new treatment modalities. In the last decade, Malaysia has emerged as a leading country of choice for Clinical Research. This bears testament to Clinical Research becoming an increasingly important sector in the country. Don't miss our Introductory Series on Clinical Research, as we bring forth experts in Industry Sponsored Trials (ISR) to share insights on this exciting career path. Meet our Speakers for this Introductory Series on Clinical Research on 19 November at PhAMA Office from 9:00 AM – 1:00 PM. Places are limited - Register now to reserve a spot! To register, kindly click here http://t2u.asia/e/38512 EeLaine Tan | Lay Ee Yeap | Irvine Pang Ming Hock | Audrey Ooi | Sheikh Mohammad Nor Hafiz 

On 5 November 2024, PhAMA had the honour of jointly organising a full-day workshop with the Pharmaceutical Services Programme (PSP), Ministry Of Health, Malaysia (KKM) on ‘Insights into New Guidelines 2024’ at Sheraton Hotel, Petaling Jaya. This impactful workshop brought together key stakeholders from MOH and pharmaceutical industry players, creating a collaborative platform for in-depth learning, open dialogue, and knowledge exchange. Attended by almost 200 participants, the workshop provided invaluable insights into the latest Guidelines for Medicine Access Schemes (MASc) and the Guidelines for Submission of Dossier for listing into the Ministry of Health Medicines Formulary. The workshop began with an opening address by Ms Li Jin CHAN, Executive Director of PhAMA, followed by welcome remarks from Dr. Nur Sufiza binti Ahmad, Deputy Director of the Formulary Management Branch. Dr. Rosliana binti Rosli, Senior Principal Assistant Director of MOH’s Formulary Management Branch, Pharmacy Practice & Development then provided an overview of the branch, which helps industry members identify the correct personnel they will be working with. Building on this foundation, Dr. Nur Liyana Zainal Bahrin and Ms Julie Looi presented on recent advancements in the Medicine Access Schemes and Special Approval Medicines. Their sessions outlined MOH’s strategic approaches  to streamline medicine access pathways and support healthcare providers meet patient needs more effectively. The highlight of the workshop was the sharing of best practices in Budget Impact Analysis (BIA). Speakers Ms. Eng Khai Li, Ms. Nurulmaya Ahmad Saad and Ms. Colleen Choo Siew Bee from MOH’s Formulary Management Branch shared real world submissions (blinded and with consent) on common pitfalls. This information shared will help enhance the quality of dossiers submitted for formulary drug listing. The workshop ended with an interactive panel discussion, which reinforced the spirit of public and private collaborations and provided an open forum to address key challenges related to drug access through formulary listing within MOH. PhAMA extends sincere gratitude to everyone whose invaluable contributions made this workshop a success, specifically the workshop committee within PSP; the PhAMA Board of Directors; members of the Blue Book and MASc Task Forces. May this event pave the way to further collaborative efforts to enhance the healthcare system for Malaysians now and in time to come. Photo album: https://lnkd.in/geK-DWUn Sally Kuah | Jessie Leow | Deepti Saraf | Julian L. | Shi Hao L. | Wuan Yin Liew | Aeron Oh | Connie L. | Kenneth Loh | SookMun Tham | Li-Ching Kok | Nathan Kothandaraman

PRESS STATEMENT 8 Nov 2024, Kuala Lumpur…The Pharmaceutical Association of Malaysia (PhAMA) regrets that an earlier statement, published in Code Blue on 29 October 2024 on the government’s directive to Institut Jantung Negara (IJN) to switch to generic medications as a cost-containment measure, has been taken out of context. The statement had erroneously implied that the decision may compromise safety in the patients’ treatment. Briefly, the statement was in specific reference to IJN’s patient load, which mostly comprise critically ill patients, many with comorbidities, who are already stabilised on their existing treatment regime. As such, a sudden change may not be advisable without clinical justification by attending physicians. In a meeting with the Ministry of Health on 7 November 2024, PhAMA members were provided more clarity on the government’s future direction, with assurance that treatment safety and efficacy would remain topmost priority, while balancing financial considerations. Any interchangeability or substitution of generic medicines will be done with prior consultation with a patient’s physician. In the treatment of high-risk patients where the benefits of using innovative medicines outweigh the risks and costs, MOH may consider using innovative medicines, even after patent expiry. PhAMA recognises that generics and biosimilars have an equally important role to play in the healthcare system, in view of rising health needs and an increasingly ageing society. With healthcare costs on the rise, generic medications provide affordable alternatives in sustaining the healthcare system especially for the public sector. The National Pharmaceutical Regulatory Agency, under the auspices of MOH’s Pharmacy Services Programme, had been vigilantly monitoring medication registrations in the country, ensuring the safety and quality of all medicines registered have undergone rigorous bioequivalent (BE) studies. Meanwhile, PhAMA urges IJN to meet impacted pharmaceutical companies as soon as possible to discuss on the status of existing contracts and provide more clarity on the way forward. This would reduce the speculations and confusion on the media reports, and allow smooth transition of medicine change for the patients and healthcare providers in IJN. News reports: https://lnkd.in/gV7Vgxc9 https://lnkd.in/gEtFgi3m